Program Lead

Director, Combination Product Program Lead

Global Device Development (GDD) | Dublin, Ireland | Hybrid, minimum 3 days a week on-site

The Valtera Group is partnering with a global pharmaceutical company on the appointment of a Director, Combination Product Program Lead within its device development function in Dublin.

THE ROLE

GDD develops the device side of their combination products, the medicines that rely on a device to reach the patient. Much of the portfolio brings generic and complex generic injectables to market, often against tight timelines and first-to-file dynamics, alongside a growing innovation agenda.

This role leads cross-functional teams through the development and transfer of injectable drug-device products: pre-filled syringes, cartridge-based pens, autoinjectors and vial kits. It is not an administrative PMO role. The team needs a leader who can read the drug side of a programme, understanding why API viscosity, a filling challenge or an impurity profile could move a timeline, and translate that into realistic plans.

You will represent GDD in senior cross-functional forums, influencing through credibility rather than formal authority. After an initial settling-in period, you will take on line management of Program Leads.

WHAT YOU'LL DO

• Lead injectable combination product programmes from feasibility through transfer to commercial manufacturing
• Own the integrated view of each programme: milestones, critical path, risks, budget and resources
• Work with drug product R&D to interrogate formulation, API and filling risks and reflect them in plans
• Review, approve or author design review reports and design and development plans
• Ensure programmes meet design control, quality and regulatory expectations for combination products
• Contribute to the strategy and workplan for the Injectables Portfolio, including prioritisation across therapeutic area partners
• Contribute to device CMC strategy supporting global registrations
• Partner with external CMOs and teams across GDD and the wider organisation.
• Report to global leadership and deliver clear executive presentations on status, risks and recommendations
• Help GDD mature towards a strategic portfolio and programme management model

WHAT YOU'LL BRING

Essential

• Degree in pharmaceutical science or a related discipline (pharmacy, chemistry, biochemistry). Engineering degrees considered where backed by substantial drug product experience
• Extensive experience in combination product or drug delivery device development, including at least 5 years in a leadership role
• Substantial drug-side experience: drug product development, formulation, technical operations, MSAT or fill-finish
• A track record of leading complex cross-functional programme teams in pharma or biotech, including taking a drug delivery device programme through development, scale-up and launch
• Knowledge of design controls with integrated risk management, human factors and usability engineering
• Applied understanding of ISO 13485, ISO 14971, ISO 11608, ISO 11040 and 21 CFR Part 820 (QMSR)
• Knowledge of pen injectors, autoinjectors, vial kits, prefilled syringes and inhalers
• Experience with project planning tools (e.g. Microsoft Project, Smartsheet, Planisware) and resource, risk and budget management
• Experience working with external partners, including CMOs
• Strong communication skills, with experience presenting to and influencing senior leaders
• Ability to work on-site in Dublin at least 3 days a week

Desirable

• PFS and cartridge-based pen experience
• Generics, biosimilars or other fast-moving development environments
• Line management or mentoring of programme or project leads
• Experience shaping portfolio governance or a PMO
• Device CMC content for global regulatory submissions
• Technology transfer to manufacturing sites, including global sites
• Exposure to inhaled or transdermal combination products
• MSc, PhD, MBA or project management qualification

WHY THIS ROLE

• Genuine work at the drug-device interface on products that matter to patients
• Visibility with GDD leadership and senior cross-functional forums
• A clear path to line leadership and a broader portfolio remit
• The chance to shape how a function manages its portfolio
• Competitive salary and bonus, health insurance and pension

To discuss the role confidentially, contact Fleur Waterston, Client Partner, Valtera Group.